Surgical fastener applying apparatus

ABSTRACT

An improved surgical fastener applying apparatus includes a cartridge half-section and an anvil half-section with the cartridge and anvil half-sections being relatively movable from an unclamped position to a fully clamped position. The apparatus includes a replaceable staple cartridge assembly having a plurality of surgical staples and a pivotably mounted safety lock-out. The safety lock-out is pivotable between an initial position in which a relative movement of the cartridge and anvil half-sections to the fully clamped position is permitted and a blocking position in which a relative movement of the cartridge and anvil half-sections to return them to their fully clamped position after the plurality of staples have been at least partially fired is prevented. The apparatus further includes a pivotably mounted firing lever for moving a pair of camming surfaces longitudinally. In addition, each of the presently disclosed cartridge and anvil half-sections of the fastener applying apparatus includes a clamping lever, which clamping levers are configured and adapted to enable the applying apparatus to be opened by either one of the cartridge half-section and the anvil half-section.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/356,912, filed Feb. 16, 2006, which is a divisional of U.S. patentapplication Ser. No. 11/292,736 filed Dec. 2, 2005 now U.S. Pat. No.7,140,527, which is a divisional of U.S. patent application Ser. No.10/399,071 filed Apr. 10, 2003 now U.S. Pat. No. 7,055,730, which is anational of PCT Serial No. PCT/US2001/032213 filed Oct. 15, 2001, whichclaims priority to U.S. Provisional Patent Application Ser. No.60/240,461 filed Oct. 13, 2000, the disclosures of which areincorporated herein in their entirety by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical fastener applying apparatusand more particularly to surgical fastener appliers for sequentiallyapplying a plurality of surgical fasteners to body tissue.

2. Discussion of Related Art

Surgical devices wherein tissue is first grasped or clamped betweenopposing jaw structures and then joined by means of surgical fastenersare well known in the art. In some such instruments a knife is providedto cut the tissue which has been joined by the fasteners. The fastenersare typically in the form of surgical staples however, other surgicalfasteners may also be utilized, for example, clips or two part polymericsurgical fasteners.

Instruments for applying surgical fasteners typically include twoelongated beam members which are respectively used to capture or clamptissue therebetween. Typically, one of the beam members carries adisposable cartridge which houses a plurality of staples arranged in atleast two lateral rows while the other beam member comprises an anvilwhich defines a surface for forming the staple legs as the staples aredriven from the cartridge. Where two part fasteners are used, this beammember carries the mating part, e.g. the receiver, to the fastenersdriven from the cartridge. Generally, the staple formation process iseffected by the interaction between a longitudinally moving cammingsurface and a series of individual staple pusher member. As the cammingsurface travels longitudinally through the cartridge carrying member,the individual pusher members are biased laterally acting upon thestaples to sequentially eject them from the cartridge. A knife maytravel with the pusher between the staple rows to longitudinally cut thetissue between the rows of formed staples. Examples of such instrumentsare disclosed in U.S. Pat. Nos. 3,079,606 and 3,490,675.

A later stapler disclosed in U.S. Pat. No. 3,499,591 applies a doublerow of staples on each side of the incision. This is accomplished byproviding a cartridge assembly in which a cam member moves through anelongate guide path between two sets of staggered staple carryinggrooves. Staple drive members are located within the grooves and arepositioned in such a manner so as to be contacted by the longitudinallymoving cam to effect ejection of the staples.

SUMMARY

It is an object of the present invention to provide a surgical fastenerapplying apparatus which apparatus will not fire if a disposable staplecartridge is not properly loaded within the apparatus or is not loadedin the apparatus at all.

It is another object of the present invention to provide a surgicalfastener applying apparatus which will not open during the firing strokeof the apparatus.

It is a further object of the present invention surgical fastenerapplying apparatus which will not accept a completely fired or apartially fired disposable staple cartridge therein.

It is yet another object of the present invention to provide a surgicalfastener applying apparatus which will not fire while in an unclampedstate.

The presently disclosed apparatus includes a cartridge half-section andan anvil half-section with the cartridge and anvil half-sections beingrelatively movable from an unclamped position to a fully clampedposition. The apparatus further includes a replaceable staple cartridgeassembly receivable in the cartridge half-section. The cartridgeassembly includes a plurality of surgical staples abutting a pluralityof staple pusher members and a pivotably mounted safety lock-out Thesafety lock-out is pivotable between an initial position, which permitsa relative movement of the cartridge and anvil half-sections to thefully clamped position, and a blocking position, which prevents arelative movement of the cartridge and anvil half-sections fromreturning to the fully clamped position after the plurality of stapleshave been at least partially fired. The apparatus further includes apair of camming surface extensions extending from a cam bar channel andpositioned within the cartridge half-section and a pivotably mountedfiring lever operatively associated with the pair of camming surfaces tomove the pair of camming surfaces longitudinally, thereby sequentiallyfiring the plurality of surgical staples in a direction transverse to adirection of travel of the pair of camming surfaces.

In addition, each of the presently disclosed cartridge and anvilhalf-sections of the fastener applying apparatus includes a clampinglever, which clamping levers are configured and adapted to enable theapplying apparatus to be opened by either one of the cartridgehalf-section and the anvil half-section. The apparatus including a clamplatch configured and adapted to retain the clamp levers in a clampedorientation and a safety interlock assembly configured and adapted toprevent opening of either of the clamping levers after the firing leverhas been moved distally.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed surgical fastenerapplying apparatus will be described herein with reference to theaccompanying drawing figures wherein:

FIG. 1 is a perspective view of one embodiment of a surgical fastenerapparatus constructed in accordance with the present disclosure;

FIG. 2 is a top plan view of the embodiment of FIG. 1;

FIG. 3 is a side elevation view of the embodiment of FIG. 1;

FIG. 4 is a side elevation view of the embodiment of FIG. 1 taken fromthe opposite side of that shown in FIG. 3;

FIG. 5 is a bottom plan view of the embodiment of FIG. 1;

FIG. 6 is a front elevation view of the embodiment of FIG. 1;

FIG. 7 is a rear elevation view of the embodiment of FIG. 1;

FIG. 8 is a perspective view of a disposable staple cartridge assemblyof the presently disclosed surgical fastener applying apparatus;

FIG. 9 is a perspective view with parts separated of the disposablestaple cartridge assembly of FIG. 8;

FIG. 10 is a schematic view of a staple pusher pair;

FIG. 11 is an enlarged left distal perspective view of a staplecartridge loading and lockout mechanism;

FIG. 12 is an enlarged right side proximal perspective view of theloading and lockout mechanism of FIG. 11;

FIG. 13 is a perspective view with parts separated showing installationof a staple cartridge assembly on a cartridge half-section of thepresently disclosed surgical fastener applying apparatus;

FIG. 14 is an enlarged perspective view from the bottom of the loadingand lockout mechanism with a staple cartridge in place thereon;

FIG. 15 is an enlarged perspective view similar to FIG. 12, with astaple cartridge in place;

FIG. 16 is an enlarged side perspective view which shows the relativepositioning of the loading and lockout mechanism with a staple cartridgeinstalled and with an anvil half-section in place in a clampedcondition;

FIG. 17 is a perspective view which shows a surgical stapler apparatusafter partial or complete firing in an unclamped condition with a staplecartridge safety lockout in a locked out position;

FIG. 18 is an enlarged view of the indicated area of detail of FIG. 17;

FIG. 19 is a perspective view of the surgical stapler apparatus openedfrom an anvil half-section side with an anvil half-section clamp leveropened and a cartridge half-section clamp lever closed;

FIG. 20 is a perspective view of the surgical stapler apparatus openedfrom a cartridge half-section side with a cartridge half-section clamplever opened and an anvil half-section clamp lever closed;

FIG. 21 is a perspective view with parts separated which shows thestructural relationship of the various components of a clamp leverlockout and safety interlock mechanism;

FIG. 22 is a plan view looking down on the anvil half-section of thesurgical stapler apparatus with a firing lever in the proximal-mostposition;

FIG. 23 is a cross-sectional view taken along section line 23-23 of FIG.22;

FIG. 24 is an enlarged view of the indicated area of detail of FIG. 23;

FIG. 25 is an enlarged view of the indicated area of detail of FIG. 23;

FIG. 26 is a plan view similar to FIG. 22, which shows the firing leveradvanced distally a short distance;

FIG. 27 is a cross-sectional view taken along section line 27-27 of FIG.26;

FIG. 28 is an enlarged view of the indicated area of detail of FIG. 27;

FIG. 29 is an enlarged view of the indicated area of detail of FIG. 27;

FIG. 30 is a perspective view of the cartridge half-section of thesurgical stapler apparatus;

FIG. 31 is a perspective view of a disposable staple cartridge assemblyaccording to an alternative embodiment of the present invention;

FIG. 32 is a perspective view, with parts separated, of the disposablestaple cartridge assembly of FIG. 31;

FIG. 33 is a perspective view of the disposable staple cartridgeassembly as shown in FIG. 31 with the shipping wedge removed therefrom;

FIG. 34 is a perspective view of a cartridge half-section according tothe alternative embodiment of the present invention;

FIG. 35 is an enlarged left distal perspective view of a staplecartridge loading and lockout mechanism;

FIG. 36 is an enlarged right side proximal perspective view of theloading and lockout mechanism of FIG. 35;

FIG. 37 is an enlarged perspective view, as seen from the bottom of theloading and lock out mechanism, according to the alternative embodimentof the present invention, with a staple cartridge in place thereon;

FIG. 38 is a partially exploded enlarged perspective view, as seen fromthe bottom of the loading and lock out mechanism shown in FIG. 38;

FIG. 39 is an enlarged perspective view similar to FIG. 36, with astaple cartridge in place;

FIG. 40 is an enlarged side perspective view which shows the relativepositioning of the loading and lockout mechanism with a staple cartridgeinstalled and with an anvil half-section in place in a clampedcondition;

FIG. 41 is a perspective view of the surgical stapler apparatus openedfrom an anvil half-section side with an anvil half-section clamp leveropened and a cartridge half-section clamp lever closed;

FIG. 42 is a perspective view of the surgical stapler apparatus openedfrom a cartridge half-section side with a cartridge half-section clamplever opened and an anvil half-section clamp lever closed;

FIG. 43 is a perspective view with parts separated which shows thestructural relationship of the various components of a clamp leverlockout and safety interlock mechanism;

FIG. 44 is a cross-sectional view of the surgical stapler taken alongthe longitudinal center line thereof;

FIG. 45 is an enlarged view of the indicated area of detail of FIG. 44;

FIG. 46 is an enlarged view of the indicated area of detail of FIG. 44;

FIG. 47 is a cross-sectional view of the surgical stapler taken alongthe longitudinal center line thereof;

FIG. 48 is an enlarged view of the indicated area of detail of FIG. 47;

FIG. 49 is an enlarged view of the indicated area of detail of FIG. 47;

FIG. 50 is a perspective view of the cartridge half-section of thesurgical stapler apparatus after partial or complete firing with astaple cartridge safety lockout in a locked out position; and

FIG. 51 is a perspective view of the surgical stapler apparatus openedfrom both the cartridge half-section side with the cartridgehalf-section clamp lever opened and from the anvil half-section sidewith the anvil half-section clamp lever opened.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed surgical fastenerapparatus will now be described in detail with reference to the drawingfigures wherein like reference numerals identify similar or identicalstructural elements. As shown in the drawings and described throughoutthe following description, as is traditional when referring to relativepositioning on a surgical instrument, the term “proximal” refers to theend of the apparatus which is closer to the user and the term “distal”refers to the end of the apparatus which is further away from the user.

Referring initially to FIG. 1, an illustrative embodiment of thepresently disclosed surgical fastener apparatus is illustrated thereinand designated generally as surgical stapler 10. Surgical stapler 10 isparticularly adapted to apply a plurality of adjacent rows of staples tobody tissue clamped in between the instrument's two principle sections,a cartridge receiving half-section 12 and an anvil half-section 14.Typical applications of the presently disclosed surgical fastenerapparatus are, for example, creating a hemostatic seal in general,thoracic, and urologic surgery for resection, transection and creationof anastomoses. Specific tissue structures in which the instrument maybe used are, for example, the stomach, the large and small bowels, lungsand the esophagus.

FIGS. 1-7 illustrate one preferred overall ornamental design for thepresently disclosed surgical fastener applying apparatus wherein. Eachof these various figures illustrates surgical stapler 10 with an anviltip removed to illustrate the end cross-section profile of the anvilhalf-section. The anvil tip is the same as the tip on the distal end ofthe staple cartridge.

Referring to FIGS. 8-10, surgical stapler 10 is designed for use with adisposable staple cartridge assembly such as single use disposableloading unit (“SULU”) 16 includes a cartridge body 18, a plurality ofstaple pusher members 20, a bottom cover 22, a knife 24 having an angledsharpened leading edge 24 a, a plurality of staples 26, a pivotablymounted safety lockout 28 and a removable shipping wedge 30. As withknown staple cartridge designs, cartridge body 18 has a plurality ofrows of staple retaining slots 32 formed therein. Surgical stapler 10may be manufactured and assembled in different sizes to receivedifferent size SULUs 16. For example, surgical stapler 10 can be made indifferent sizes to accept SULUs having staple line lengths of 60 mm, 80mm, and 100 mm.

Alternatively, SULUs 16 may be adapted such that one common surgicalstapler 10 will accept multiple different staple count SULUs. Forexample, SULUs 16 may be configured such that each different staplecount SULU shares a common size cartridge body 18 to facilitate mountingon surgical stapler 10.

In the illustrated embodiment, there are two staggered rows of slots 32formed on either side of a linear slotted track 34 which guides knife 24during its longitudinal movement. A single staple 26 is positioned ineach of slots 32. The staple rows preferably extend a distance distallybeyond the distal end of knife track 34 to facilitate staple formationbeyond the stroke length of knife 24.

Staple pushers 20 are aligned one each with slots 32 such that a singlestaple pusher 20 is positioned under the staple 26 retained in slot 32.Staple pushers 20 are formed such that they are attached to each otherin groups of two offset oriented pusher pairs, shown schematically inFIG. 10, and have an actuating surface connecting each pair of twopushers 20.

The pusher pairs are arranged in two series, one on each side of slottedtrack 34, such that the actuating surfaces of each series of pusherpairs forms a line centered between the staggered row of staples 26. Theactuating surfaces act as cam followers and interact with a pair ofstaggered camming surfaces 36, 38 (see FIG. 11) extending from a cam barchannel 40 to expel the pairs of staples 26 on each side of the knifetrack 34. As illustrated, camming surfaces 36, 38 form a single anglerelative to horizontal. In certain application, for example, withstaples having an unformed leg height of about 4.5 mm, camming surfaces36, 38 may be formed of a plurality of angles to facilitate optimalstaple deformation with a given firing force. As cam bar channel 40 ismoved distally this sequence is repeated until the distal movement ofcam bar channel 40 is either stopped intentionally by the user to formless than all of staples 26 or until all of staples 26 are expelled fromSULU 16.

Bottom cover 22 partially encloses the bottom of a channel formed by theupper surface and side walls of cartridge body 18. A longitudinal ridge22 a is formed on the upper surface of bottom cover 22 and serves as abearing surface for knife bearing channel 42 secured to the bottom-edgeof knife 24 as it travels in knife track 34. A pair of slots are formedone on either side of longitudinal ridge 22 a. The outer limit of eachslot being defined by the outer wall of cartridge body 18 on therespective side of ridge 22 a. These slots facilitate reciprocatinglongitudinal movement of the camming surface extensions 36, 38 of cambar channel 40. Knife bearing channel 42 which is wider than knife track34, is secured to the bottom surface of the knife such that knifebearing channel member 42 rides between knife track 34 and longitudinalridge 22 a of bottom cover 22. In this manner, knife 24 is preventedfrom undergoing substantial vertical movement during longitudinaltranslation in knife track 34.

Safety lockout 28 is pivotably disposed on the upper proximal end ofcartridge body 18 and is movable from a locked orientation to anunlocked orientation. Preferably, safety lockout 28 is biased away fromthe locked orientation towards an orientation substantiallyperpendicular to the longitudinal axis of cartridge body 18. Anysuitable bias member may be utilized such as, for example, springs 44,46. To overcome the bias towards the perpendicular orientation, safetylockout 28 includes a transverse horizontal surface 28 a (see FIG. 24)formed on the underside thereof which engages a hook 24 b formed on theupper edge surface of knife 24. This cooperative engagement serves toretain safety lockout 28 in the locked orientation wherein safetylockout 28 covers knife 24.

When surgical stapler 10 has been unclamped, as will be described ingreater detail further herein, after either partial or complete firing,safety lockout 28 is biased to the perpendicular orientation (see FIGS.17 and 18), extending upwardly away from cartridge half-section 12. Inthis manner, surgical stapler 10 cannot be re-clamped until the partialor completely fired SULU 16 is removed and replaced with a new SULU 16.Safety lockout 28 also provides a cut-out grasping surface 28 b withwhich SULU 16 may readily be removed from surgical stapler 10.

As previously noted, shipping wedge 30 is removably attachable tocartridge body 18. When installed on SULU 16, shipping wedge 30 coversthe entire surface area of the staple rows 26 and knife track 34.Additionally, shipping wedge 30 includes an abutment 30 a extendingupwardly and proximally from the upper proximal surface of shippingwedge 30. Abutment 30 a in cooperation with-safety lockout 28 coverssharpened distal edge 24 a of knife 24. This feature prevents the knifefrom being exposed to the user during handling of SULU 16. Additionally,abutment 30 a prevents pivotal movement of safety lockout 28 from thelocked orientation. Thus, even if SULU 16 is properly loaded on surgicalstapler 10, staples 26 cannot be fired until shipping wedge 30 is firstremoved.

Shipping wedge 30 also includes a post 30 b extending downwardly fromthe underside near the proximal end. Post 30 b fits into a complementaryshaped opening 18 c formed in cartridge body 18 at the proximal end ofknife track 34. With shipping wedge 30 in place, post 30 b blockspotential distal movement of knife 26. In an alternative embodiment,SULUs 16 may also be provided without a knife in applications where itis desirable to perform stapling without transection. In such anembodiment, knife 26 is replaced with a blank element to substitute forthe knife to interact with safety lockout 28.

Cartridge body 18 is provided with several molded surfaces to facilitatemounting and alignment of SULU 16 with respect to cartridge half-section12 of surgical stapler 10. Such alignment facilitating surfaces may beformed at any suitable location on the various components of cartridgebody 18 to correspond with complementary surfaces on cartridgehalf-section 12. In the illustrated embodiment, locating/alignmentfeature surfaces 18 a are formed extending downwardly on either side ofSULU 16 near the proximal end thereof and molded surfaces 18 b areformed on either side of cartridge body 18 near the distal end thereof.When SULU 16 is properly installed on surgical stapler 10, surfaces 18 aseat in a pair of notches 48, 50 (see FIG. 13) formed in cartridgehalf-section 12.

Referring to FIGS. 11-16, a loading and lockout mechanism for SULU 16will now be described in detail. In these figures, a channel frame 12 a(see FIG. 21) of cartridge half-section 12 is not shown so that theloading and lockout mechanism can be illustrated more clearly. Theloading and lockout mechanism facilitates loading of SULU 16 andprevents firing of surgical stapler 10 until SULU 16 is properly loadedon cartridge half-section 12 and surgical stapler 10 is properly clampedshut. The loading and lockout mechanism includes a rocker 52 which ispivotably mounted to channel frame 12 a (see FIG. 21) of cartridgehalf-section 12 by way of transversely extending post portions 52 aseating in openings formed through the sidewalls of channel frame 12 a.Post portions 52 a are provided with angled downwardly oriented surfacesto facilitate assembly of rocker 52 with channel frame 12 a. Rocker 52is preferably a molded plastic component and is provided with threeslots, namely an open bottomed slots 52 b, 52 c to permit longitudinalmovement of cam bar channel 40 and a closed slot 52 d to permit passageof a center bar 54.

As best shown in FIGS. 12 and 14, rocker 52 is further provided with adownwardly extending blocking surface 52 e which is in verticalalignment with an opening formed through the bottom surface of cam barchannel 40 when cam bar channel 40 is in its proximal-most position.Rocker 52 is biased, by way of a spring 56 being disposed betweendownwardly extending leg 52 f and an end wall 58 a of a beam member 58,toward a locked-out position wherein blocking surface 52 e extendsthrough opening 40 a. In this manner, cam bar channel 40 is preventedfrom distal longitudinal movement. In versions of surgical stapler 10using shorter SULUs 16, beam 58 may be eliminated.

Upon loading of SULU 16 on cartridge half-section as shown in FIG. 15and 16, the spring bias maintains rocker 52 in the locked-out position.It is only when anvil half-section 14 is joined with cartridgehalf-section 12 and the half-sections clamped together thereby causingdownwardly extending leg portions 60 a formed on either side of anvilhalf-section channel member 60 to bias against SULU 16, that rocker 52is urged to rotate by the camming action of proximal end surface of SULU16 against the distal end surface of rocker 52. In this manner, blockingsurface 52 e is moved out of longitudinal alignment with opening 40 a ofcam bar channel 40 thereby permitting distal longitudinal movementthereof.

Referring to FIGS. 17 and 18, once surgical stapler 10 has been at leastpartially fired, if the instrument is opened, safety lockout 28 of SULU16 automatically moves to the perpendicular orientation due to thespring bias mounting thereof. In this orientation, surgical stapler 10cannot be re-clamped. Thus, if the user desires to apply furtherstaples, SULU 16 must first be removed and replaced with a non-firedSULU 16.

Referring to FIGS. 19-21, surgical stapler 10 is provided with dualselectable clamping levers 62, 64 and a pivotably mounted firing lever65. Clamping levers 62, 64 provide the user with the uniquely noveloption of opening surgical stapler 10 from either half-section 12 or 14.Additionally, firing lever 65 provides the user with the ability to firesurgical stapler 10 from either the left or right side.

Clamping levers 62, 64 are pivotably mounted to cartridge half-section12 and anvil half-section 14, respectively. A pair of ergonomiccontoured handles 66, 68 are secured to clamping levers 62, 64,respectively to provide the user with a convenient gripping handle. Tofurther enhance the gripping of surgical stapler 10 by the user, a pairof friction enhancing inserts 70, 72 are secured to handles 66, 68.Inserts 70, 72 may be formed of any suitable friction enhancingmaterials, for example, rubber. Half-sections 12 and 14 are preferablyconfigured and dimensioned to provide the ability for the user to reacharound both halves and comfortably close surgical stapler 10 with aone-handed operation to approximate the captured tissue.

Referring to FIGS. 21-23, 25-27 and 29, a clamp latch and safetyinterlock mechanism is provided at the proximal end of surgical stapler10. The clamp latch and safety interlock mechanism serves to retainclamp levers 62, 64 in a clamped orientation as well as to provide asafety interlock which prevents opening of either clamp lever 62, 64once firing lever 65 is moved distally. Each half section 12 and 14 isprovided with a clamp latch and safety interlock assembly which isessentially the same and which work to latch clamp levers 62, 64 in aclamped configuration upon squeezing the clamp levers 62, 64 to theclosed position. Accordingly, the following description of the variouscomponents which make up the assembly will be directed to that for thecartridge half-section 12 as shown in FIG. 21.

The clamp latch and safety interlock mechanism includes a distal clamplever latch 74 and a proximal interlock latch 76 which is spring biaseddistally toward a latched position. When surgical stapler 10 is in theclamped configuration with firing lever 65 in the proximal-mostposition, a firing slide block 78 biases latch 76 proximally to overcomethe distal spring bias, as shown in FIG. 25, to position ledge 76 a oflatch 76 out of lateral alignment with proximal ledge 74 a formed onlatch 74 thereby positioning latch 76 in an unlatched position. In thisposition, the user may either clamp lever 62, 64 by squeezing springbiased finger pad portions 80 a, 80 b of latch handle release member 80which urges latch 74 proximally such that distal ledge 74 b is moved outof lateral alignment with the blocking structure formed on cartridgehalf-section 12 a or anvil half-section 14 a (not shown).

Once firing lever 65 is moved distally to begin the firing sequence ofsurgical stapler 10, as shown in FIGS. 26, 27 and 29, slide block 78also moves distally thereby removing the biasing force which overcamethe distal spring bias of latch 76. Thus, ledge 76 a moves in to lateralalignment with ledge 74 a of latch 74 thereby preventing clamp lever 62from being opened until firing lever 65 is once again moved to theproximal-most position. The instrument is thereby prevented from openingduring the firing stroke.

Upon initial distal movement, firing lever 65 becomes locked-out frompivotal movement by way of firing lever 65 being cammed downwardly toovercome an upward spring bias, as shown in the operationallyprogressive views of FIGS. 25 and 29. in particular, as best shown inFIG. 30, recessed notches 65 a, 65 b are formed as keyways which engagea key 78 a formed on slide block 78, respectively depending upon whichside firing lever 65 is rotated to during firing. Firing lever 65 can bereturned to the proximal-most position at any time during the firingstroke. Firing lever 65 must be returned to the proximal-most positionbefore the levers can be released and the instrument unclamped. Asdescribed previously, if the instrument is opened after firing eitherpartially or completely, safety lockout 28 on SULU 16 is configured toprevent the user from re-clamping the instrument.

Turning now to FIGS. 31-51, an alternative embodiment of a disposablestaple cartridge assembly is generally shown as 116. Staple cartridgeassembly 116 includes a cartridge body 118, a plurality of staple pushermembers 120, a bottom cover 122, a knife 124 having an angled sharpenedleading edge 124 a, a plurality of staples 126, a pivotably mountedsafety lockout 128 and a removable shipping wedge 130. As with knownstaple cartridge designs, cartridge body 118 has a plurality of rows ofstaple retaining slots 132 formed therein.

Alternatively, cartridge assembly 116 may be adapted such that onecommon surgical stapler 100 (see FIGS. 41 and 42) will accept multipledifferent staple count cartridge assemblies 116. For example, cartridgeassembly 116 may be configured such that each different staple countcartridge assembly 116 shares a common size cartridge body 118 tofacilitate mounting on surgical stapler 100.

In the present illustrated embodiment, there are two staggered rows ofslots 132 formed on either side of a linear slotted track 134 whichguides knife 124 during its longitudinal movement. A single staple 126is positioned in each of slots 132. The staple rows preferably extend adistance distally beyond the distal end of knife track 134 to facilitatestaple formation beyond the stroke length of knife 124. Staple pushers120 are formed such that they are attached to each other in groups oftwo offset oriented pusher pairs.

The pusher pairs are arranged in two series, one on each side of slottedtrack 134, such that the actuating surfaces of each series of pusherpairs forms a line centered between the staggered row of staples 126.The actuating surfaces act as cam followers and interact with a pair ofstaggered camming surfaces 136 and 138 (see FIGS. 34-36) extending froma pair of cam bars 140 to expel the pairs of staples 126 on each side ofthe knife track 134. As illustrated, camming surfaces 136 and 138 form asingle angle relative to horizontal. As each cam bar 140 is moveddistally this sequence is repeated until the distal movement of each cambar 140 is either stopped intentionally by the user to form less thanall of staples 126 or until all of staples 126 are expelled fromcartridge assembly 116.

Bottom cover 122 partially encloses the bottom of a channel formed bythe upper surface and side walls of cartridge body 118. A longitudinalridge 122 a is formed on the upper surface of bottom cover 122 andserves as a bearing surface for knife bearing channel 142, secured tothe bottom edge of knife 124, as knife 124 travels in knife track 134. Apair of slots are formed one on either side of longitudinal ridge 122 a.The outer limit of each slot being defined by the outer wall ofcartridge body 118 on the respective side of ridge 122 a. These slotsfacilitate reciprocating longitudinal movement of the camming surfaceextensions 136, 138 of each cam bar 140. Knife bearing channel 142 whichis wider than knife track 134, is secured to the bottom surface of theknife such that knife bearing channel member 142 rides between knifetrack 134 and longitudinal ridge 122 a of bottom cover 122. In thismanner, knife 124 is prevented from undergoing substantial verticalmovement during longitudinal translation in knife track 134.

Safety lockout 128 is pivotably disposed on the upper proximal end ofcartridge body 118 and is movable from a locked orientation to anunlocked orientation. Preferably, safety lockout 128 is biased away fromthe locked orientation towards an orientation substantiallyperpendicular to the longitudinal axis of cartridge body 118. Anysuitable bias member may be utilized such as, for example, spring 144.To overcome the bias towards the perpendicular orientation, safetylockout 128 includes a transverse horizontal surface 128 a (see FIG. 45)formed on the underside thereof which engages a hook 124 b formed on theupper edge surface of knife 124. This cooperative engagement serves toretain safety lockout 128 in the locked orientation when safety lockout128 covers knife 124.

When surgical stapler 100 has been unclamped, as will be described ingreater detail further herein, after either partial or complete firing,safety lockout 128 is biased to the perpendicular orientation (see FIG.50), extending upwardly away from cartridge half-section 112. In thismanner, surgical stapler 100 cannot be re-clamped until the partial orcompletely fired cartridge assembly 116 is removed and replaced with anew cartridge assembly 116. Safety lockout 128 also provides a cut-outgrasping surface 128 b with which cartridge assembly 116 may readily beremoved from surgical stapler 100.

As previously noted, shipping wedge 130 is removably attachable tocartridge body 118. When installed on cartridge assembly 116, shippingwedge 130 covers the entire surface area of the staple rows 126 andknife track 134. Shipping wedge 130 includes a post 130 b extendingdownwardly from the underside near the proximal end thereof. Post 130 bfits into a complementary shaped opening 118 c formed in cartridge body118 at the proximal end of knife track 134. With shipping wedge 130 inplace, post 130 b blocks potential distal movement of knife 126. Post130 b maintains knife 134 retained within safety lockout 128 therebyensuring that the sharpened distal edge 124 a of knife 124 is covered.Once again, cartridge assembly 116 may be provided without a knife inapplications where it is desirable to perform stapling withouttransection. In such an embodiment, knife 126 is replaced with a blankelement to substitute for the knife to interact with safety lockout 128.

Cartridge body 118 includes a series of finger grips 127 formed alongthe upper sides of the body 118 near a proximal end thereof. The fingergrips 127 assist the user in gripping the cartridge assembly 116 forboth installation and removal of the cartridge assembly 116 from thecartridge half-section 112. Cartridge body 118 also includes a pair ofresilient friction fingers 129 disposed on either side near a proximalend thereof. Friction fingers 129 are configured and adapted to projectoutwardly from the cartridge body 118 and to frictionally engage theinner surface of the cartridge half-section 112. In this manner, thefriction fingers 129 prevent the cartridge assembly 116 from falling outof the cartridge half-section 112.

Referring to FIGS. 35-40, a loading and lockout mechanism for cartridgeassembly 116 will now be described in detail. The loading and lockoutmechanism facilitates loading of cartridge assembly 116 and preventsfiring of surgical stapler 100 until cartridge assembly 116 is properlyloaded on cartridge half-section 112 and surgical stapler 100 isproperly clamped shut. The loading and lockout mechanism includes arocker 152 which is pivotably mounted to a channel frame 112 a (see FIG.43) of cartridge half-section 112 by way of transversely extending postportions 152 a seating in openings formed through the sidewalls ofchannel frame 112 a. Post portions 152 a are provided with angleddownwardly oriented surfaces to facilitate assembly of rocker 152 withchannel frame 112 a. Rocker 152 is preferably a molded plastic componentand is provided with three slots, namely an open bottomed slots 152 b,152 c to permit longitudinal movement of cam bar channel 140 and aclosed slot 152 d to permit passage of a center bar 154.

As best shown in FIGS. 37 and 39, rocker 152 is further provided with adownwardly extending blocking surface 152 e which is in verticalalignment with an opening 140 a formed through the bottom surface ofeach cam bar 140 when each cam bar 140 is in its proximal-most position.Rocker 152 is biased, by way of a spring 156 which is disposed ontransversely extending post portion 152 a and between a ridge 152 fformed on a side of the rocker 152 and upper surface of the cartridgehalf section 112 (see FIG. 35), toward a locked-out position whereinblocking surface 152 e extends through opening 140 a. In this manner,each cam bar 140 is prevented from distal longitudinal movement.

Upon loading cartridge assembly 116 on cartridge half-section 112 asshown in FIGS. 37-40 and, the spring bias maintains rocker 152 in thelocked-out position. It is only when anvil half-section 114 is joinedwith cartridge half-section 112 and the half-sections clamped togetherthereby causing downwardly extending leg portions 160 a formed on eitherside of anvil half-section channel member 160 to bias against cartridgeassembly 116, that rocker 152 is urged to rotate by the camming actionof proximal end surface of cartridge assembly 116 against the distal endsurface of rocker 152. In this manner, blocking surface 152 e is movedout of longitudinal alignment with opening 140 a of each cam bar 140thereby permitting distal longitudinal movement thereof.

Similar to the first embodiment, once surgical stapler 100 has been atleast partially fired, if the instrument is opened, safety lockout 128of cartridge assembly 116 automatically moves to the perpendicularorientation due to the spring bias mounting thereof. In thisorientation, surgical stapler 100 cannot be re-clamped. Thus, if theuser desires to apply further staples, fired or partially firedcartridge assemblies 116 must first be removed and replaced with anon-fired cartridge assembly 116.

Referring to FIGS. 41 and 42, surgical stapler 100 is provided with dualselectable clamping levers 162 and 164 and a pivotably mounted firinglever 165. Like clamping levers 62 and 64 of the first embodiment,clamping levers 162 and 164 of the present embodiment provide the userwith the uniquely novel option of opening surgical stapler 100 fromeither half-section 112 or 114. Additionally, firing lever 165 providesthe user with the ability to fire surgical stapler 100 from either theleft or right side.

Clamping levers 162 and 164 are pivotably mounted to cartridgehalf-section 112 and anvil half-section 114, respectively. Clampinglevers 162 and 164 provide the user with the ability to open thesurgical stapler from either the anvil half-section 114, as seen in FIG.41, the cartridge half-section 112, as seen in FIG. 42, orsimultaneously from both the cartridge half-section 112 and the anvilhalf-section 114, as seen in FIG. 51. A pair of ergonomic contouredhandles 166 and 168 are secured to clamping levers 162 and 164,respectively to provide the user with a convenient gripping handle. Tofurther enhance the gripping of surgical stapler 100 by the user, a pairof friction enhancing inserts 170 and 172 are secured to handles 166 and168.

Unlike the first embodiment, the surgical stapler 100 according to thealternative embodiment does not have a safety interlock mechanism. Inthis manner, the user can open the surgical stapler 100 after a completeor partial firing of the cartridge assembly 116. Referring now to FIGS.43-49, a clamp latch mechanism, according to the alternative embodiment,is provided at the proximal end of surgical stapler 100 which serves toretain clamp levers 162 and 164 in a clamped orientation. Each halfsection 112 and 114 is provided with a clamp latch mechanism which isessentially the same and which works to latch clamp levers 162 and 164in a clamped configuration upon squeezing the clamp levers 162 and 164to the closed position. Accordingly, the following description of thevarious components which make up the clamp latch mechanism will bedirected to that for the cartridge half-section 112.

As shown in FIG. 43, the clamp latch mechanism includes a distal clamplever latch 174 formed at a proximal end of the cartridge half-section112 and latch handle release member 180 operatively coupled to aproximal end of clamp lever 162. Latch handle release member 180 isspring biased proximally toward a latched position and is provided witha catch 182 or engaging clamp lever latch 174. In order to release clamplever 162, the user presses release member 180 in the distal direction,thereby disengaging catch 182 from latch 174.

In order to prevent inadvertent opening of the clamp lever 162, releasemember 180 is provided with a projection 184 extending downwardly from aproximal end thereof, which projection 184 is seated within a guard 186formed at the proximal end of the lever 162. It is envisioned that theguard 186 can be integral with the handles 166 and 168 and made of aresilient material to enable the user to more easily move the guard 186and thereby depress the release member 180.

Further, as seen in FIG. 43, surgical stapler 100 is provided with afiring lever slide block 188. Slide block 188 include a hub 190projecting therefrom and configured and adapted to be received in apivot hole 192 formed in firing lever 165. Slide block 188 is configuredand adapted to be slidably received in either the cartridge half-section112 or the anvil half-section 114. In use, the firing lever 165 ispivotable about hub 190 thereby providing the user with the ability tomanipulate the firing lever 165 from either side of the surgical stapler100.

As seen in FIGS. 41-43 and 50, surgical stapler 100 is provided with astaple gap adjustment mechanism 200 which enables each stapler 100 to bemanufactured and assembled with a very precise staple gap between thecartridge assembly and the anvil structure of the surgical stapler. Thestaple gap adjustment mechanism 200 is the subject of commonly owned andco-pending U.S. provisional patent application, Ser. No. 60/327,369,filed on Oct. 5, 2001, entitled “Surgical Stapling Apparatus”, attorneydocket number 203-3067, the entire contents of which are incorporatedherein by reference. According to the present embodiment, gap adjustmentmechanism 200 includes a pair of upstanding hinge plates 202 formedalong the sides of the cartridge half-section 112 and an eccentric cam206. Each hinge plate 202 is provided with a coaxial through hole 204formed therein and is configured and adapted to receive the eccentriccam 206 therein. In use, as the eccentric cam 206 is rotated, theeccentric cam 206 presses against the anvil half-section 114 until thedesired staple gap between the anvil half-section 114 and the cartridgehalf section 112 is achieved. At which point the eccentric cam 206 isfixedly secured in the through holes 204.

It will be understood that various modifications may be made to theembodiments of the surgical fastener applying apparatus disclosedherein. Therefore, the above description should not be construed aslimiting, but merely as exemplifications of preferred embodiments. Thoseskilled in the art will envision other modifications within the scopeand spirit of the present disclosure.

1. A surgical fastener applying apparatus, comprising: a cartridgehalf-section supporting a pair of camming surface extensions extendingfrom a cam bar arrangement; an anvil half-section, said cartridge andanvil half-sections being relatively movable from an unclamped positionto a clamped position; a first clamp lever operatively connected to thecartridge half-section and a second clamp lever operatively connected tothe anvil half-section; wherein each clamp lever is movable between afirst position in which the cartridge and anvil half sections are in theunclamped position, and a second position in which the cartridge andanvil half sections are in the clamped position; and a pivotably mountedfiring lever operatively associated with said pair of camming surfaceextensions to move said pair of camming surface extensionslongitudinally to thereby sequentially fire said plurality of surgicalstaples in a direction transverse to a direction of travel of said pairof camming surface extensions, wherein the firing lever is pivotable toextend to a right side and left side of the apparatus.
 2. The surgicalfastener applying apparatus of claim 1, wherein the cartridge and anvilhalf-sections may be unclamped from one another upon actuation of atleast one of the first and second clamp levers.
 3. The surgical fastenerapplying apparatus of claim 1, wherein at least one of the cartridge andanvil half-sections includes a clamp lever latch configured and adaptedto retain a respective first and second clamp lever in the clampedposition.
 4. The surgical fastener applying apparatus of claim 3,wherein each clamping lever includes a latch handle release member, eachlatch handle release member is biased in a proximal direction, eachlatch handle release member engages a respective first and second clamplever when said respective first and second clamp lever is in saidclamped position.
 5. The surgical fastener applying apparatus of claim4, wherein distal movement of said latch handle release member resultsin disengagement from said respective first and second clamp lever. 6.The surgical fastener applying apparatus of claim 5, wherein each ofsaid first and second clamp levers includes a clamp lever latchconfigured and adapted to selectively engage a respective one of saidlatch handle release members.
 7. The surgical fastener applyingapparatus of claim 1, further comprising a replaceable staple cartridgeassembly receivable in said cartridge half-section, said cartridgeassembly including a plurality of surgical staples.
 8. The surgicalfastener applying apparatus of claim 3, wherein each clamp lever latchprevents opening of either clamp lever once staple firing is initiated.